standards (e.g. iso mdd ansi etc.)

  1. A

    IATF 16949 Internal Audit Checklist

    I am tasked with getting an internal audit team to audit all elements of the IATF standard in a 3 year period. I have no $ to purchase software to have questions and checklists available for using. I am going to start our audits in February and have sections 5.1, 5.2 , 5.3 and 8.1, 8.2 to...
  2. P

    Usability/human factors engineering requirement (standard) for IVD medical device

    Dear All, Merry Christmas and Happy New Year, Just want to check whether anyone has a summary or a list of requirements for usability/human factors engineering, including standards (e.g. CLSI or others) specifically for IVD medical devices. I know that there was "GP14-A Labeling of Home-Use In...
  3. E

    Do standards have performance reviews?

    For example, when a new ISO standard is released, does that process go through a Management Review with CAPAs? If a new standard is released, how does the committee prove it is effective to improve/control performance? What metrics are used?
  4. M

    ASTM A6 Material Standard - Section Nominal Sizes

    I'm hoping this is considered the right sub thread for this type of question. I'm doing some research for my current company and its all realated to the standard C channel we purchase. The ASTM A6 standard is pretty clear except when defining what the section nominal sizes are. Would that...
  5. D

    Raw Material chemical/Tensile Requirements Specifications (QQ-A-250/4, etc)

    When I receive raw material (aluminum, steel, etc) and verify the actual properties to the specification (QQ-A-250/4, etc) I have to have the actual specification, in the latest revision. Is there a place or a service that provides the chemical/tensile requirements for raw material such as this...
  6. M

    Updates to EN 62366 & ISO 14971?

    Hi Everyone! I recently got an email notifying me of some upcoming changes/edits to the EN 62366 and ISO 14971 standards: EN 62366-1:2015 The email said there is a corrigendum (EN 62366-1:2015/AC:2018), but I've been unable to find any further information. Closest thing I could find is a 2016...
  7. L

    What are the rules on significance of digits in numbers in IEC/ISO standards?

    Hi, Maybe a lack of search skills, but I cannot find any indication or referral in the standards like the 60601-1 we have right now (we cannot afford to buy them all) on how to interpret the significance of the last digit of values. My late science teacher hammered on the notion that the...
  8. M

    Plating standards - Where to find information

    It looks like I might have to purchase the AMS 2417 Nickel plating standard. Currently this is at rev. J (09-2013). I have heard that standards get reviewed/revised every 5 years or so. I don't want to purchase if the standard is currently being revised or will be within the next few months...
  9. C

    Where to buy the latest MHLW, Canada MDR, Brazil medical device regulations

    Hello, Is there one website that I can get, buy, download the latest MHLW, Canada MDR, Brazil regulations for medical devices? Or if you have the sites you use for each one will be fine too. Thank you,
  10. S

    Virtual manufacturers/OEM - CE/ISO requirements

    Hi all, we(as a virtual manufacturer) want to add few OEM products in our product list and sell those products in our name and also put CE marking. The OEM already have CE. Can we put "manufactured by" our address and use their CE marking. or shall we get the technical file from...
  11. Marc

    Where do you buy your ISO and other various standards?

    Standards are expensive, however many times a standard can be purchased cheaper in certain countries. What standards have you purchased, and did you explore to get the best price? For example, ISO wants CHF138 which is US$147 for ISO 9001:2015 - Where can it be bought cheaper? How about...
  12. K

    Where does the FDA post its various compliance dates?

    Good Afternoon, Does anyone know if and where the FDA posts its various compliance dates? Either to an updated standard like IEC 60601-1 3rd edition for example, or things like UDI direct marking. I know the due dates for those it was just an example. Thank you:thanx:
  13. QMMike

    ISO (in search of) IATF 16949 vs. TS 16949 changes summed up

    Sorry if it's been asked before --- I've looked and didn't notice if it was -- Does a document exist - or does anyone have a document that simply breaks down exactly what the changes are? In all honesty, reading the entire specification and looking for changes is daunting and seems like...
  14. Ajit Basrur

    Informational ISO/IEC 17025:2017 Published - November 2017

    ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories. ISO/IEC 17025:2017 is applicable to all organizations performing...
  15. W

    Standard for Micrometer Anvil Flatness

    Hi there, I hope someone can help me... our Global Quality manager wants to update our Calibration acceptance criteria to the DoD standard; this would change our current .0005" Flatness to .00005". We are training to find standards that support our argument that this change is necessary and...
  16. T

    External Standard Update Notification

    An internal audit found our company to not have the most recent ASTM standard. My question is how or what tools are there out there in the internet world that can email a contact here to notify them there was an update released? (not just for ASTM but for other Aerospace/Defense related...
  17. T

    ISO 9004:2018 Revision - Released April 2018

    Have the proposed changes to ISO 9004 been published yet? Anyone know where I could find a draft copy of ISO 9004:2018? thanks, thenson
  18. D

    EU Harmonized Standards to which a company has declared compliance

    I'm in the process of reviewing a list of standards to which a company has declared compliance for their product. I am unsure if some standards noted as harmonized on this list are currently harmonized in the EU as they are not listed on the relevant page on the EC website (which contains a...
  19. I

    Quality Manual Upgrade from AS9100 C to D

    Hello, I have a question regarding the upgrading of our Quality manual from AS9100C to D. I apologize in advance if this is a stupid question but I really need some advice. My current manual matches the AS9100C standard. For example, section 7.4 Purchasing in the standard is section 7.4...
  20. J

    Use of Harmonised Standards (Full or Partial)

    Cove Users, Could anybody give me good examples of when a (Harmonised) standard is used in full, and when one is used partially? And what defines Full & Partial Many Thanks
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